Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07
Route
OPHTHALMIC
Published
Effective Date 2023-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Aminomethylpropanol Boric Acid Guar Gum Polidronium Chloride Potassium Chloride Water Sodium Chloride Hydrochloric Acid Sodium Hydroxide Edetate Disodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-10-24 Until 2024-04-30
Description

Active ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

Medication Information

Description

Active ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

Uses
  • temporary relief of burning and irritation due to dryness of the eye
  • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 55105-1
Active ingredients Purpose
Polyethylene Glycol 400 0.4% Lubricant
Propylene Glycol 0.3% Lubricant
Warnings

For external use only

Directions
  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Questions?

In the U.S. call 1-800-757-9195

[email protected]

www.systane.com

Other Information
  • store at room temperature
Inactive Ingredients

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Package Label.principal Display Panel

DAY & NIGHT VALUE PACK



Systane®



ULTRA

LUBRICANT EYE DROPS



HIGH PERFORMING DRY EYE RELIEF



DAYTIME



Fast-acting hydration and lasting relief

 Moisture-rich formula

#1 DOCTOR RECOMMENDED BRAND1



GEL DROPS

LUBRICANT EYE GEL



SOOTHING DRY EYE RELIEF



NIGHTTIME



Long-lasting formula

 Day or night protection



LIQUID GEL

STERILE



Two 10 mL Bottles (1/3 FL OZ EACH)



Alcon®



This Value Pack

gives you fast-acting

hydration and

long-lasting relief,

for day or night

protection.



ACTUAL SIZE BOTTLES

TAMPER EVIDENT: For your

protection, each bottle has an

imprinted seal around the neck.

Do not use if seal is damaged or

missing at time of purchase.



www.alconpatents.com



ALCON LABORATORIES, INC.

Fort Worth, TX 76134 USA 



Made in USA from domestic and

foreign materials



300048647-0621

 

LOT:

EXP.:

Systane® ULTRA

LUBRICANT EYE DROPS



HIGH PERFORMANCE

STERILE

10 mL (1/3 FL OZ)



FOR EXTERNAL USE ONLY.



INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.



DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.



WARNINGS: See carton for WARNINGS.



INGREDIENTS:



Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.



Inactives: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.



Store at room temperature. 



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



Alcon®



LOT:



EXP.:



300055616-1221

Systane ® GEL DROPS

LUBRICANT EYE GEL



Soothing Dry Eye Relief



STERILE

10 mL (1/3 FL OZ)



FOR EXTERNAL USE ONLY.



Uses: See carton for USES.



WARNINGS: See carton for WARNINGS.



Directions: Shake well and put 1 or 2 drops in the affected eye(s) as needed.  



INGREDIENTS:



Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%.



Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Store at room temperature. 



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Alcon



LOT:

EXP.:



300048641-0621

Structured Label Content

Uses
  • temporary relief of burning and irritation due to dryness of the eye
  • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 55105-1 (55105-1)
Active ingredients Purpose
Polyethylene Glycol 400 0.4% Lubricant
Propylene Glycol 0.3% Lubricant
Warnings

For external use only

Directions
  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Questions?

In the U.S. call 1-800-757-9195

[email protected]

www.systane.com

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

DAY & NIGHT VALUE PACK



Systane®



ULTRA

LUBRICANT EYE DROPS



HIGH PERFORMING DRY EYE RELIEF



DAYTIME



Fast-acting hydration and lasting relief

 Moisture-rich formula

#1 DOCTOR RECOMMENDED BRAND1



GEL DROPS

LUBRICANT EYE GEL



SOOTHING DRY EYE RELIEF



NIGHTTIME



Long-lasting formula

 Day or night protection



LIQUID GEL

STERILE



Two 10 mL Bottles (1/3 FL OZ EACH)



Alcon®



This Value Pack

gives you fast-acting

hydration and

long-lasting relief,

for day or night

protection.



ACTUAL SIZE BOTTLES

TAMPER EVIDENT: For your

protection, each bottle has an

imprinted seal around the neck.

Do not use if seal is damaged or

missing at time of purchase.



www.alconpatents.com



ALCON LABORATORIES, INC.

Fort Worth, TX 76134 USA 



Made in USA from domestic and

foreign materials



300048647-0621

 

LOT:

EXP.:

Systane® ULTRA

LUBRICANT EYE DROPS



HIGH PERFORMANCE

STERILE

10 mL (1/3 FL OZ)



FOR EXTERNAL USE ONLY.



INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.



DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.



WARNINGS: See carton for WARNINGS.



INGREDIENTS:



Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.



Inactives: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.



Store at room temperature. 



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



Alcon®



LOT:



EXP.:



300055616-1221

Systane ® GEL DROPS

LUBRICANT EYE GEL



Soothing Dry Eye Relief



STERILE

10 mL (1/3 FL OZ)



FOR EXTERNAL USE ONLY.



Uses: See carton for USES.



WARNINGS: See carton for WARNINGS.



Directions: Shake well and put 1 or 2 drops in the affected eye(s) as needed.  



INGREDIENTS:



Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%.



Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Store at room temperature. 



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Alcon



LOT:

EXP.:



300048641-0621

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.926831 · Updated: 2026-03-14T23:02:08.105317